Trial Master File Operations Specialist

San Francisco, CA

Contract To Perm

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as a Trial Master File Operations Specialist. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Tracks laboratory samples and follows up with sites/study team/CRO to resolve queries
  • Develops ability to organize and manage large datasets and present regular summaries to teams
  • Ensures 3rd party vendor deliverables are of high quality and in line with study timelines
  • Designs/develops protocol-specific laboratory manuals, study tools and presentations to be utilized for training study site staff
  • Interacts with investigators, study coordinators and study teams/CROs through written and verbal communication to maintain effective management of specimen management issues ensuring accuracy and completeness
  • Assists with manual in-house review of CRF data in clinical database for completeness and accuracy
  • Assists with review of clinical/regulatory documents pertaining to research use of bio-specimens including informed consent forms, site-and country-specific applications related to bio-specimens, to ensure completeness, accuracy and timeliness
  • Ensures study records are auditable both at investigational sites, in-house and at off-site bio-repository and analytical labs, if applicable
  • Develops independence in performing routine work and assists in designing metrics to evaluate efficiency of overall sample management process
  • Communicates status of trial to manager and team

REQUIREMENTS

  • Biological experience and/or understanding of various DNA, RNA and protein based biomarker assays and application to our drug candidates and companion diagnostics
  • Experience in translational medicine research and/or clinical research in an academic or bio-pharmaceutical setting
  • Proficient with clinical and biological data management
  • Experience managing central lab and third party vendors and ensuring data is generated and transferred in compliance with recommended procedures
  • Background knowledge of cellular and molecular biology, common biological assays (eg: microarrays, sequencing etc.) and drug development processes
  • Self-motivated and capable of working effectively in a fast-paced team environment
  • Excellent presentation and oral/written communication skills
  • Excellent verbal and written communication skills
  • Successful candidates must possess outstanding organizational skills and be able to focus on details with commanding follow through
  • Working knowledge of GCP and FDA regulations
  • Proficiency in MS Word, Excel and PowerPoint
  • Very limited, if any travel

EDUCATION

  • BA/BS in Molecular/Cellular Biology, Pharmacology or equivalent, with 3+ years relevant industry experience 

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application


Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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